Summary Safety Review - Tramadol-containing Products - Assessing the Potential Risk of Serious Breathing Problems (Respiratory Depression) in Children and Adolescents (English, HTML)

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Publisher-reported update

2024-05-10

The product information for tramadol warns of the risk of serious breathing problems when too much is taken. Health Canada's safety review on codeine (another opioid drug) to study the risk of serious breathing problems in children and adolescents triggered this review for tramadol. Tramadol is an opioid drug authorized in Canada for the treatment of moderate to moderately severe pain but is not recommended for use in patients under 18 years of age. However, Health Canada is aware that this drug is being used in children and adolescents (known as off-label use).

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